Protein Eating Patterns and Weight Loss
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Even protein
Skewed protein
Sponsored by

About this trial
This is an interventional other trial for Obesity focused on measuring Protein, Weight Loss
Eligibility Criteria
Inclusion Criteria:
- BMI 28-45 kg/m2
Exclusion Criteria:
- unable or unwilling to consume animal products
- unable or unwilling to attend treatment group meetings
- had more than a 10% change in body weight in the 2 months prior to study start date
- consuming a specialized diet
- have a history of and eating or gastrointestinal disorder
- currently or planning on becoming pregnant during the study timeline
- lactating
- have an uncontrolled metabolic illness/disease (fasting glucose >125 mg/dL)
- have uncontrolled hypertension (>160/99 mm Hg)
- have cancer or in short-term remission (less than 3 years)
- have an infectious disease
- suffer from alcohol or drug abuse
- use tobacco and/or e-cigarette products on a regular basis
- taking medications known to affect energy expenditure and appetite
Sites / Locations
- USDA Grand Forks Human Nutrition Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Even protein intake
Skewed protein intake
Arm Description
Menu to provide 90 g of protein per day in an even distribution of 30 g at each meal.
Menu to provide 90 g of protein per day in a skewed distribution of 10 g at breakfast, 15 g at lunch and 65 g at dinner.
Outcomes
Primary Outcome Measures
Body Composition
Determine the effects of two patterns of daily protein intake on changes in fat mass and fat-free mass during weight loss.
Diet Adherence
Determine the effects of two patterns of daily protein intake on weight loss diet adherence and putative mediators (satisfaction, satiety, hunger, and reinforcing value of energy dense foods) of adherence.
Secondary Outcome Measures
Barriers to weight control
Nominal Group Technique results providing an exhaustive list of barriers to weight control in overweight and obese women
Change in skeletal muscle protein breakdown
The effect of consuming two patterns of daily protein intake on 3-Methylhistidine degradation, a biochemcial marker of skeletal muscle protein breakdown
Circulating carotenoid levels
The effect of consuming two patterns of protein intake during weight loss on circulating carotenoid levels.
Relative reinforcing value (RRV) of food
The effect of consuming two patterns of daily protein intake during weight loss on the RRV of energy-dense snack food
Change in bone turnover
The effect of consuming two patterns of daily protein intake during weight loss on osteocalcin, alkaline phosphatase, acid phosphatase, and collagen cross-link molecules -- biochemical markers of bone formation and resorption
Plasma lipids
The effect of consuming two patterns of daily protein intake during weight loss on lipid and triglyceride molecular speciation.
Full Information
NCT ID
NCT03202069
First Posted
June 26, 2017
Last Updated
June 27, 2023
Sponsor
USDA Grand Forks Human Nutrition Research Center
Collaborators
North Dakota Beef Commission
1. Study Identification
Unique Protocol Identification Number
NCT03202069
Brief Title
Protein Eating Patterns and Weight Loss
Official Title
Effect of Daily Protein Intake Patterns During Weight Loss on Dietary Adherence and Body Composition in Women
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
April 14, 2023 (Actual)
Study Completion Date
April 14, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
USDA Grand Forks Human Nutrition Research Center
Collaborators
North Dakota Beef Commission
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the effects of daily protein intake patterns on body composition and eating behaviors during weight loss.
Detailed Description
The reinforcing value of food varies greatly among individuals, but is strongest for those who are overweight or obese. Reducing energy intake, which is necessary for overweight and obese individuals to achieve a healthier body weight, increases the reinforcing value of food - especially for energy-dense snack foods. Food is a powerful reinforcer and is associated with energy intake; making it a primary contributing factor to an individual's weight loss struggle. Developing a way to decrease or limit the increase in food reinforcement during energy deficits would have important clinical impact. High-protein diets are known to be efficacious for weight loss and recently have been shown to decrease stimulation of the reward areas of the brain that stimulate reward-driven eating behavior. Nonetheless, sustaining a high-protein diet can be difficult, especially for women. Consuming a modest amount of protein at each meal may be better tolerated. However, we do not know whether this pattern of protein intake can assist women in staying "on track" with weight loss goals. This study will help begin to elucidate the connections between the daily pattern of protein intake on diet adherence, alterations in food reinforcement, and favorable body composition changes during weight loss.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Protein, Weight Loss
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Even protein intake
Arm Type
Experimental
Arm Description
Menu to provide 90 g of protein per day in an even distribution of 30 g at each meal.
Arm Title
Skewed protein intake
Arm Type
Experimental
Arm Description
Menu to provide 90 g of protein per day in a skewed distribution of 10 g at breakfast, 15 g at lunch and 65 g at dinner.
Intervention Type
Other
Intervention Name(s)
Even protein
Intervention Description
Intake of even protein 5 day rotating menu
Intervention Type
Other
Intervention Name(s)
Skewed protein
Intervention Description
Intake of skewed protein 5 day rotating menu
Primary Outcome Measure Information:
Title
Body Composition
Description
Determine the effects of two patterns of daily protein intake on changes in fat mass and fat-free mass during weight loss.
Time Frame
8 and 16 weeks
Title
Diet Adherence
Description
Determine the effects of two patterns of daily protein intake on weight loss diet adherence and putative mediators (satisfaction, satiety, hunger, and reinforcing value of energy dense foods) of adherence.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Barriers to weight control
Description
Nominal Group Technique results providing an exhaustive list of barriers to weight control in overweight and obese women
Time Frame
1 hour
Title
Change in skeletal muscle protein breakdown
Description
The effect of consuming two patterns of daily protein intake on 3-Methylhistidine degradation, a biochemcial marker of skeletal muscle protein breakdown
Time Frame
8 and 16 weeks
Title
Circulating carotenoid levels
Description
The effect of consuming two patterns of protein intake during weight loss on circulating carotenoid levels.
Time Frame
8 and 16 weeks
Title
Relative reinforcing value (RRV) of food
Description
The effect of consuming two patterns of daily protein intake during weight loss on the RRV of energy-dense snack food
Time Frame
8 and 16 weeks
Title
Change in bone turnover
Description
The effect of consuming two patterns of daily protein intake during weight loss on osteocalcin, alkaline phosphatase, acid phosphatase, and collagen cross-link molecules -- biochemical markers of bone formation and resorption
Time Frame
8 and 16 weeks
Title
Plasma lipids
Description
The effect of consuming two patterns of daily protein intake during weight loss on lipid and triglyceride molecular speciation.
Time Frame
8 and 16 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI 28-45 kg/m2
Exclusion Criteria:
unable or unwilling to consume animal products
unable or unwilling to attend treatment group meetings
had more than a 10% change in body weight in the 2 months prior to study start date
consuming a specialized diet
have a history of and eating or gastrointestinal disorder
currently or planning on becoming pregnant during the study timeline
lactating
have an uncontrolled metabolic illness/disease (fasting glucose >125 mg/dL)
have uncontrolled hypertension (>160/99 mm Hg)
have cancer or in short-term remission (less than 3 years)
have an infectious disease
suffer from alcohol or drug abuse
use tobacco and/or e-cigarette products on a regular basis
taking medications known to affect energy expenditure and appetite
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shanon Casperson, PhD
Organizational Affiliation
USDA Grand Forks Human Nutrition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA Grand Forks Human Nutrition Research Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.ars.usda.gov/plains-area/gfnd/gfhnrc/docs/nutrition-studies/nutrition-studies/
Description
Grand Forks Human Nutrition Research Center Current Nutrition Studies
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Protein Eating Patterns and Weight Loss
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